FILE NAME: XXXXX September 16 , 2009

EPA Registration Division contact: Janet Whitehurst (703) 305 - 6129 [ 9F7617 ] Valent USA Corporation EPA has received a pesticide petition (9F7617) from Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.627, by

e stablishing a tolerance for residues of the fungicide chemical fluopicolide, 2,6
- dichloro -N
- [3
- chloro
- 5
- (trifluoromethyl)
- 2
-py ridylmethyl]
-benzamide , as an indicator of combined residues of fluopicolide and its metabolite, 2,6

–dichlorobenzamide (BAM), in or on the raw agricultural commodity v egetable Brassica (cole), leafy, subgroup 5B , at 20 ppm resulting from the proposed use as a fungicide. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency o f the submitte d data at this time or whether the data supports granting of the petition. A dditional data may b e needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism
. The metabolism of fluopicolide in crop plants has been reported previously

and is adequately

understood for the purpose of granting the proposed tolerances. 2. Analytical method. Practical anal ytical methods for detecting and measuring levels of fluopicolide and its metabolites have been developed and validated in/on all appropriate plant and animal matrices. An anal ytical method for detecting fluopicolide and BAM in mustard greens has been submitted with this petition. The LOQ of fluopicolide and the metabolite in the anal ytical method for mustard greens is 10 ppb (0.01 ppm), which will allow monitoring for residues at the levels proposed for the tolerances. 3. Magnitude of residues
. Residue data for the use of fluopicolide on mustard greens has been submitted which adequatel y support the proposed tolerances. B. Toxicological Profile The toxicological profile and toxicological endpoints for fluopicolide and BAM supporting this petition for tolerances was published in the Federal Register on January 3 0, 2008 (Volume 73, Number 20) and May 28, 2008 (Volume 73 Number 103). C. Aggregate ExposureAn assessment was conducted to evaluate potential risks due to chronic dietary ( food and water) and non - dietary

(residential turf) exposure of the U.S. population subgroups to residues of fluopicolide for all current and pending indoor and outdoor uses of fluopicolide including Crop Group 1 (Root and Tuber Vegetables), Crop Group 3 (Bulb vegetables), Crop Group 4 (L eafy Vegetables, Except Brassica ), Crop Group 5 ( Brassica (Cole) leafy

v egetables), Crop Group 8 (Fruiting Vegetables), Crop Group 9 (Cucurbit Vegetables), Grape, Turf, and Ornamentals. The Cumulative and Aggregate Risk Evaluation System (CARES) Version 3.0b was used to conduct the fluopicolide dietary and non
- dietary

exposure assessments using highl y conservative, tolerance
-based assumptions. Because fluopicolide is not acutely toxic and not carcinogenic, no acute or cancer exposure assessment was performed. 1. Dietary exposure. i. Food. Dietary

exposure (food) assessments were conducted to evaluate the potential risk due to chronic dietary exposure of the U.S. population and various subgroups to tolerance level residues of fluopicolide in/on the proposed new crops as well as crops for which there are existing tolerances. Proposed tolerance
- level residues, default processing values and 100% percent crop treated were used for the assessment. ii. Drinking water. Surface (drinking) water concentrations were calculated by the Environmental Fate and Effects Division (EFED) and can be found in: “Drinking Water Exposure and Assessment for Fluopicolide Uses on Grapes, Vegetables, Potatoes and Turf”. The most conservative value, the 1
- in
- 10 ye ar annual mean (non
- cancer chronic) derived from modeling fluopicolide used on California lettuce with aerial applications, was used in this dietary assessment. This value was imported into the CARES Water Module in order to calculate drinking water risks. 2. Non
- dietary exposure
. There is a potential residential exposure to adults and children entering residential turf areas treated with fluopicolide.. The following post
- application exposure scenarios were evaluated: adults and toddler (children 1
- 2) incidental dermal exposure, and toddler exposure from hand
- to - mouth transfer or object
- to - mouth transfer from p esticide
treated residential areas. A dermal absorption value of 37% was used in the assessment. The amount of material considered available for transfer was 10% with a daily decay rate of 10%. 3. Aggregate Exposure Assessment. The aggregate risk ass essment includes food, water and residential turf exposures. An acute risk assessment was not conducted because there was no acute toxicology

endpoint identified. For the chronic risk assessment scenarios, the endpoint utilized was 20 mg/kg/day based on the rabbit developmental toxicity study. No additional FQPA factor was used (1X). For the dietary

(food) chronic 99.9 th percentile exposure pathway, children ages 1
- 2 were the highest exposed group with 11.8 %cPAD and a MOE of 848. For drinking water, the 99.9 th percentile exposure was highest in infants, yet the %cPAD in all cases was <1% (MOE >26,945). In the case of residential turf exposures, MOEs were greater than 400 for all subpopulations. Based on these risk assessments, the exposure for all routes and all populationsubgroups do not exceed EPA’s level of concern (<100%cPAD).

D. Cumulative Effects Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency c onsider “available infor mation” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity”. EPA does not have, at this time, available data to determine whether fluopicolide has a common mechanism of tox icity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, EPA has not assumed that fluopicolide has a common mechanism of toxicity with other substances. E. Safety Determination 1. U.S. population
. Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub
-populations) by

including the incremental exposure resulting from the proposed uses of fluopicolide. 2. Infan ts and children
. Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub
-populations) by

including the incremental exposure resulting from the proposed uses of fluopicolide. F. International To lerances Below is a chart of established fluopicolide tolerances/MRL’s in major countries. Country Commodity MRL (mg/kg) European Union Leafy Brassicas (Chinese cabbage, pak choi,

Chinese flat cabbage, peking cabbage, cow cabbage, kale, Borecole (curly kale) collards) 0.1* * temporary

EU MRLs